BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER OSC GTS ST HUB 90MM X 25MM X 1.27MM

    MDR report key: 4929420 · Received July 21, 2015

    Report

    Report Number
    2950261-2015-00010
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 31, 2015
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS NOTED BY THE REPORTER THAT THE PRODUCT IS RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED TO DOVER. THE REPORTED EVENT THAT "TABS ON THE END OF THE BLADE BROKE OFF DURING USE WAS CONFIRMED BASED ON PHOTO EVIDENCE PROVIDED BY THE CUSTOMER DISPLAYING A BROKEN BLADE. ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME AS THE BLADE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION OR EVIDENCE THAT WOULD SUPPORT A SPECIFIC ROOT CAUSE WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS IT WAS REPORTED TO HAVE BEEN DISPOSED OF BY THE HOSPITAL. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. DISPOSED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABS ON THE END OF THE BLADE BROKE OFF DURING USE, BOTH TABS HAD BROKEN. THE BLADE WAS BEING USED ON A STRYKER SYSTEM 6 SAW DURING A TOTAL KNEE PROCEDURE WHILE CUTTING THROUGH A 5 IN 1 FEMORAL CUTTING GUIDE. THERE WAS A SURGICAL DELAY OF 10 MINUTES AND AN ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION PROVIDED INDICATED THAT NO PORTION OF THE BROKEN DEVICE WAS FOUND IN THE SURGICAL SITE. AN X-RAY WAS TAKEN INTRAOPERATIVELY TO CONFIRM THAT THE BROKEN PIECES WERE NOT IN THE SURGICAL SITE, CAUSING THE REPORTED 10 MINUTE DELAY. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473638 ZIMMER OSC GTS ST HUB 90MM X 25MM X 1.27MM ZIMMER OSC GTS ST HUB 90MM X 25MM X 1.27MM GFA SYNVASIVE TECHNOLOGY, INC. 53169

    Patients

    Seq Age Sex Outcome Treatment
    1